John Theurer Cancer Center Launches Clinical Trial of Personalized Cancer Vaccine Using New Gene-Based Technology for High-Risk Melanoma

Researchers hope the vaccine, combined with immunotherapy, can reduce the risk of relapse in patients after melanoma surgery

News provided by

Hackensack Meridian Health

Feb 28, 2020, 11:45 ET

HACKENSACK, N.J., Feb. 28, 2020 /PRNewswire/ -- John Theurer Cancer Center at Hackensack University Medical Center is the only site in New Jersey and one of just 17 in the country participating in a multicenter international Phase II study of an innovative personalized cancer vaccine being evaluated in combination with pembrolizumab immunotherapy in patients with melanoma that has been surgically removed but has a high risk of coming back. The hope is that the vaccine can prime a patient's immune system to be more responsive to immunotherapy and reduce the risk of cancer recurrence. Utilizing a novel and potentially revolutionary gene-based technology, the vaccine is created by comparing the patient's normal cell DNA sequence to that of their tumor and identifying tumor specific changes to the DNA. Once identified, the patient-specific, tumor-specific changes are turned into a messenger RNA construct to be used as a vaccine.

Pembrolizumab belongs to a class of drugs called "checkpoint inhibitors," which have transformed the treatment of melanoma. It works by blocking a protein called PD-1 which normally shuts down the immune response. Cancer cells use PD-1 to hide from the immune system. Inhibiting PD-1 enables the immune system to find and kill cancer cells.

"Pembrolizumab and other checkpoint inhibitors have been shown to reduce disease recurrence among patients with high-risk melanoma that was surgically removed. However, in many patients, the cancer eventually comes back," explained Andrew L. Pecora, M.D., FACP, CPE, a nationally recognized hematologist/oncologist at John Theurer Cancer Center and associate dean, Technology and Innovation, Hackensack Meridian School of Medicine at Seton Hall University, who is a principle investigator (PI) of the study. "Reducing the rate of relapse would address a significant unmet medical need for these patients."

The study, "A Phase II Randomized Study of Adjuvant Immunotherapy with the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab versus Pembrolizumab Alone after Complete Resection of High-Risk Melanoma," is assessing a vaccine made by ModernaTX, Inc. called mRNA-4157. A personalized vaccine is made and given back to the patient to trigger the immune response.

John Theurer Cancer Center was also a study site for the Phase I clinical trial of the vaccine, which was assessed alone and in combination with pembrolizumab in patients with a variety of solid tumors. The results, which were presented at the 2019 Annual Meeting of the American Society of Clinical Oncology, were promising — showing that mRMA-4157 was well tolerated, provoked an immune response, and resulted in clinical responses when given with pembrolizumab.

"Immunotherapy is revolutionizing cancer care, but challenges remain. This is a very exciting customized anticancer vaccine using a novel technology," noted Martin E. Gutierrez, M.D., director of Drug Discovery and the Phase I Unit, chief of Thoracic Oncology at John Theurer Cancer Center, and a PI of the Phase I study. "We are encouraged by the Phase I findings and are hopeful that the Phase II study results will show a similar positive outcome for these patients."

"Participation in groundbreaking studies such as these demonstrates John Theurer Cancer Center's leadership in clinical research," added Andre Goy, M.D., MS, chair and executive director of John Theurer Cancer Center. "We are committed to offering our patients the latest medical advances and furthering progress in cancer care through clinical investigation."

"Hackensack University Medical Center is delivering cutting-edge cancer treatments options for our patients," said Ihor Sawczuk, M.D., FACS, president, Northern Region, chief research officer, Hackensack Meridian Health. "By utilizing gene-based technology, we are offering patients hope with a personalized cancer vaccine that can boost immune responses and reduce the risk of relapse for melanoma patients."

"Hackensack University Medical Center is advancing research and innovation to discover new treatment options for our patients," said Mark D. Sparta, FACHE, president and chief hospital executive, Hackensack University Medical Center and executive vice president of Population Health, Hackensack Meridian Health. "We look forward to seeing how this innovative vaccine and advances in immunotherapy will help us expand treatment options for patients with melanoma."

ABOUT HACKENSACK MERIDIAN HEALTH

Hackensack Meridian Health is a leading not-for-profit health care organization that is the largest, most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care.

Hackensack Meridian Health comprises 17 hospitals from Bergen to Ocean counties, which includes three academic medical centers – Hackensack University Medical Center in Hackensack, Jersey Shore University Medical Center in Neptune, JFK Medical Center in Edison; two children's hospitals - Joseph M. Sanzari Children's Hospital in Hackensack, K. Hovnanian Children's Hospital in Neptune; nine community hospitals – Bayshore Medical Center in Holmdel, Mountainside Medical Center in Montclair, Ocean Medical Center in Brick, Palisades Medical Center in North Bergen, Pascack Valley Medical Center in Westwood, Raritan Bay Medical Center in Old Bridge, Raritan Bay Medical Center in Perth Amboy, Riverview Medical Center in Red Bank, and Southern Ocean Medical Center in Manahawkin; a behavioral health hospital – Carrier Clinic in Belle Mead; and two rehabilitation hospitals - JFK Johnson Rehabilitation Institute in Edison and Shore Rehabilitation Institute in Brick.

Additionally, the network has more than 500 patient care locations throughout the state which include ambulatory care centers, surgery centers, home health services, long-term care and assisted living communities, ambulance services, lifesaving air medical transportation, fitness and wellness centers, rehabilitation centers, urgent care centers and physician practice locations. Hackensack Meridian Health has more than 35,000 team members, and 7,000 physicians and is a distinguished leader in health care philanthropy, committed to the health and well-being of the communities it serves.

John Theurer Cancer Center part of HMH, is one of only 16 NCI Designated Cancer Consortium in partnership with Georgetown Lombardi. In addition, HMH has partnered with Memorial Sloan Kettering to accelerate discovery and make sure patients have access to the highest quality, most individualized cancer care when and where they need it.

The network's notable distinctions include having four hospitals among the top in New Jersey by U.S. News and World Report. Other honors include consistently achieving Magnet® recognition for nursing excellence from the American Nurses Credentialing Center and being named to Becker's Healthcare's "150 Top Places to Work in Healthcare/2019" list.

The Hackensack Meridian School of Medicine at Seton Hall University opened in 2018, the first private medical school in New Jersey in more than 50 years, welcomed its second class of 96 students in 2019 to its On3 campus in Nutley and Clifton.

Hackensack Meridian Health is a member of AllSpire Health Partners, an interstate consortium of leading health systems, to focus on the sharing of best practices in clinical care and achieving efficiencies.

For additional information, please visit www.HackensackMeridianHealth.org.

About Hackensack Meridian John Theurer Cancer Center at Hackensack University Medical Center

John Theurer Cancer Center at Hackensack University Medical Center is New Jersey's largest and most comprehensive center dedicated to the diagnosis, treatment, management, research, screenings, and preventive care as well as survivorship of patients with all types of cancers. The 14 specialized divisions covering the complete spectrum of cancer care have developed a close-knit team of medical, research, nursing, and support staff with specialized expertise that translates into more advanced, focused care for all patients. Each year, more people in the New Jersey/New York metropolitan area turn to John Theurer Cancer Center for cancer care than to any other facility in New Jersey. John Theurer Cancer Center is a member of the Georgetown Lombardi Comprehensive Cancer Center Consortium, one of just 16 NCI-approved cancer research consortia based at the nation's most prestigious institutions. Housed within a 775-bed not-for-profit teaching, tertiary care, and research hospital, John Theurer Cancer Center provides state-of-the-art technological advances, compassionate care, research innovations, medical expertise, and a full range of aftercare services that distinguish John Theurer Cancer Center from other facilities. For additional information, please visit www.jtcancercenter.org.

SOURCE Hackensack Meridian Health